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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Scarring (2061); Reaction (2414)
Event Date 12/10/2020
Event Type  Injury  
Event Description
Since around (b)(6) 2020, every dexcom sensor i have applied has caused a severe rash where the adhesive touches my skin. Every single time. These rashes take weeks to heal, and if i use any other adhesive over the place the rash was before the rash is completely gone, the rash reappears and scars. I have marks on my skin today ((b)(6) 2021) from a sensor that i removed on (b)(6) 2020. I have photos of some of these rashes that i would be happy to share. Since these rashes began, i have not been able to use the decom g6 cgm that i have come to rely on to help me care for my diabetes. My average blood sugar is decidedly worse because of this issue. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11337543
MDR Text Key232378266
Report NumberMW5099420
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2021 Patient Sequence Number: 1
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